Imvexxy Approved for Moderate to Severe Dyspareunia Due to Menopause

The softgel capsule is administered intravaginally without an applicator.

The Food and Drug Administration (FDA) has approved Imvexxy (estradiol vaginal inserts; TherapeuticsMD) for the treatment of moderate-to-severe dyspareunia due to menopause.

The FDA approval was supported by findings from a Phase 3, randomized, double-blind, placebo-controlled study that evaluated Imvexxy (4mcg and 10mcg) vs placebo from baseline to week 12.

Treatment with Imvexxy led to relief of moderate to severe dyspareunia due to menopause as early as week 2 for both doses. In addition, the treatment was associated with statistically significant changes in vaginal cytology and pH. A substudy evaluating the pharmacokinetics of both Imvexxy doses showed that the mean concentration of estradiol and estrone remained within average postmenopausal range.

Headache was found to be the most frequent adverse reaction associated with Imvexxy treatment. As with other estrogen replacement therapies, the labeling for Imvexxy includes a Boxed Warning regarding the risk of endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia.

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Imvexxy will be available as 4mcg and 10mcg strength vaginal inserts in 8- and 18-count packs; the 4mcg dose represents the lowest approved dose of vaginal estradiol available. The softgel capsule is administered intravaginally without an applicator once daily for 2 weeks, followed by 1 insert twice weekly.